Job Description

Job Description

Summary:

Responsibility for the management and execution of the self-inspection (internal audit) program. Responsible for presenting the self-inspection program during corporate and external inspections, and assisting with audit readiness and inspection support activities such as Gemba walks, gap assessments and Risk management. Support additional Quality Compliance responsibilities, as needed, including: Annual Product Review, Customer Complaints, Quality Council, and license renewal support. Ensures all areas of responsibility are adhering to procedures and requirements.  Responsible for handling multiple tasks, projects, and ensuring commitments are completed on-time.  Demonstrate effectiveness in task completion, decision-making, empowering others, training, and problem solving. Notify management through timely escalation of issues that could jeopardize the effective release of acceptable product to internal and external customers.

Essential Duties and Responsibilities:

Primary duty is accountability for the self-inspection strategy, management and execution. Including, but not limited to,
Ensuring compliance with global procedures
Conduct assessment of internal departments and quality systems to ensure compliance, using applicable global quality standards, global procedures, local procedures, applicable country regulations, directives, inspection guidelines and compendia, as applicable.
Alignment with the Plasma OpU Strategy and coordinating audit and SME support to other sites as assigned
Creating a self-inspection annual schedule, communicating it out to key stakeholders and revising quarterly
Planning and leading identified self-inspections
Ensuring the Track Wise database is up to date with all self-inspections
Offering guidance, training, and support for other lead auditors, co auditors and SME’s
Training site auditees to effectively execute self-inspections and update Track Wise
Ongoing monitoring of self-inspection commitments, issuance of final reports and audit plans to meet required due dates per procedure

Additional duties in support of the department are outlined below:
Corporate, customer and external inspections - preparing pre-request documentation, compiling supporting documentation for commitments, assessing current GMP regulations and managing logistics. Responsible to track/trend action plans, provide compliance expertise and oversee closure of commitments, effectiveness checks and recommendations made by the agencies. Play a key role in the support or inspection rooms through reviewing documentation and partnering closely with business units.
Audit readiness activities - prepare meetings content, issuance of actions and meeting minutes.  Perform sweeps to ensure Good Manufacturing Practices are followed during inspection tours. Facilitate self-assessment workbook.
Responsible for maintaining Track Wise workflows: QRAMS and risk mitigation tracker to ensure compliance to procedures and timeliness of closure of corrective actions.
Assist with authoring Product Quality Reviews and Site Master File.
Responsible for the oversight and remediation of top compliance gaps and risks.
Prepare Quality Compliance slides for key quality indicators and metrics supporting local, global and OpU Quality Council.
Support License Renewals and Complaints per applicable procedures.  Monitor complaint systems to ensure timely, appropriate, and thorough resolution of issues and closure of records. 
Provide New Employee Orientation training to new employees on GMP regulations and compliance.
Actively participate in operating mechanisms at defined frequencies and provide compliance insights.
Applies problem solving methodologies. innovative solutions and drive continuous improvement initiatives.
Acts as a resource to other facilities for benchmarking and serves as a resource internally as well, interacting frequently with functional peers and senior group managers.
Remains current in knowledge of regulations and regulatory industry trends through partnership with the Regulatory Intelligence teams.
Manage activities of self to achieve defined quality goals in an efficient, accurate, and timely manner.

Qualifications:

Lead Auditors must be experienced in the types of audit they are leading.  (i.e Pharmaceutical Manufacturing, Medical Device, Global Internal and Local Self Inspection (LOC)). Thorough understanding of and knowledge of appropriate regulatory requirements, auditing standards, quality systems and production operations and regulatory requirements.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Exhibit Takeda Quality Culture Behaviors: Ensure a Speak-Up Culture, Own and Demonstrate Your Commitment to Quality, Take Pride in Doing it Right and Keep It Simple.
Exhibit Takeda values: Honesty, Integrity, Perseverance and Fairness.

Education and/or experience:

Typically requires a bachelor’s degree in science, engineering or another related technical field. 
5 years of related experience in pharmaceutical manufacturing, Quality Control or Quality Assurance.
Additional Quality Auditor certification or training is highly preferred.

Physical Demands:

Must be able to lift, push, pull and carry up to 20 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment:

Must be comfortable assessing risk, navigating ambiguity and resolving conflict.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment
Must be able to work multiple shifts, including weekends, as requested.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
10 to 20 % Travel